Company:Boston Scientific Corporation.
Date of Enforcement Report 11/15/2017
Class lI:
PRODUCT
RESONATE EL ICD VR, Model D432, Sterile.
Recall Number Z-0077-2018
REASON
The devices have an incorrect firmware configuration.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Saint Paul, MN. on 10/4/2017. Voluntary:
Firm Initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
5 devices
DISTRIBUTION
The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution
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